Spectracef (cefditoren pivoxil)

OCTOBER 01, 2003

Introduction

Spectracef, an oral antibiotic, was approved by the FDA in 2001 and will be relaunched in 2003 by Purdue Pharmaceutical Products LP under an exclusive licensing agreement with Meiji Seika Kaisha Ltd of Japan.1

Pharmacology

Spectracef is a semisynthetic, broadspectrum, third-generation cephalosporin indicated for the treatment of mild-to-moderate infections in adults and adolescents.2 It is useful in the treatment of Haemophilus influenzae, H parainfluenzae, Streptococcus pneumoniae, and Moraxella catarrhalis in acute bacterial exacerbation of chronic bronchitis and in community-acquired pneumonia (CAP).2,3 It also is useful against strains of S pyogenes in pharyngitis/tonsillitis and against S pyogenes or Staphylococcus aureus in the treatment of uncomplicated skin and skin-structure infections.4

Clinical Trials

Fogarty et al reported data from a multicenter, prospective, randomized, investigator-blinded, parallel-group study comparing the use of Spectracef and amoxicillin/clavulanate in the treatment of CAP. The study randomized 802 patients with CAP to receive either 200 or 400 mg of Spectracef twice daily or amoxicillin/clavulanate 875/125 twice daily for 14 days. Assessment was characterized as ?cure? or ?failure.? Cure rates at posttreatment visits for patients taking Spectracef 200 mg, Spectracef 400 mg, and amoxicillin/ clavulanate 875/125 were 88.0%, 89.9%, and 90.3%, respectively. At follow- up visits, the cure rates were 86.5%, 86.8%, and 87.8%, respectively.3

A randomized, double-blind, multicenter study, conducted by Bucko and colleagues, compared the use of Spectracef 200 or 400 mg bid with either cefuroxime 250 mg bid or cefadroxil 500 mg bid for the treatment of uncomplicated skin and skin-structure infections. A total of 1685 patients were enrolled, with therapy given after meals for a duration of 10 days. Patients were assessed prior to beginning the study, immediately after the discontinuation of treatment (48 hours), and at various follow-up visits thereafter. The study was divided into 2 different studies. The first compared Spectracef with cefuroxime (study 1), and the second compared Spectracef with cefadroxil (study 2). Results from study 1 showed that patients receiving Spectracef 200 and 400 mg experienced 84% clinical cure, and patients receiving cefuroxime experienced 88% clinical cure for all infections combined. In study 2, the Spectracef 200-mg group experienced 85% clinical cure, the Spectracef 400-mg group experienced 81% clinical cure, and the cefadroxil group experienced 85% clinical cure for all infections combined.

Safety

The most common adverse events seen with Spectracef (incidence >1%) are diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, and vomiting. Other more serious but less common adverse events include fever, anaphylaxis, toxic epidermal necrolysis, erythema multiforme, colitis, renal dysfunction, hepatic dysfunction, and Stevens-Johnson syndrome.2,3 Contraindications include known allergy to cephalosporin (or to other structurally similar drugs), carnitine deficiency, and present pseudomembranous colitis.

All doses should be taken with food. Spectracef, however, should not be taken simultaneously with drugs that decrease stomach acid. The use of probenecid with Spectracef may result in increased plasma concentrations of Spectracef. Spectracef tablets contain a milk protein called sodium caseinate; therefore, patients with milk protein hypersensitivity (not lactose intolerance) should avoid taking Spectracef.2

Outlook

Spectracef is comparable to other currently marketed products for the treatment of infections from various respiratory pathogens and mild-tomoderate skin infections.3,4 The recommended dose of Spectracef for CAP is 400 mg twice daily for 14 days. A 400- mg twice-daily dose of Spectracef also is recommended for acute bacterial exacerbations of chronic bronchitis; however, only a 10-day course of therapy is required. Pharyngitis/tonsillitis and uncomplicated skin and skin-structure infections have a listed recommended dose of 200 mg twice daily for 10 days.